Conventionally presterilized prefillable syringe barrels are supplied in tub and nest assemblies that are hermetically sealed to the environment to pharmaceutical customers, who then fill medicine into the presterilized nested syringe barrels under sterile conditions using filling and stoppering machines. In the market there are three types of filling and stoppering machines available, namely 1) manual machines, 2) semi automatic machines and 3) fully automatic machines.
There is one tub and nest format available in the market for pre-crimped cartridges but there are lots of disadvantages to use this existing tube and nest format with existing as well as new filling and stoppering machines because this tub and nest format requires complete setting change from infeed to outfeed for accommodating different height level of cartridge into the nest. Moreover a complete replacement of filling carriers is required for maintaining the height between the filling nozzles and the cartridge top level. Further the drawback of two different change parts needs separate validation study as per GMP (Good Manufacturing Practice) guidelines requirements. If one tries to fill the pre-crimped cartridge nest available in the market on the same machine without changing the machine height setting accidents will happen which may cause damage to the filling nozzles or glass cartridges may get broken because the height difference between the filling nozzles and the pre-crimped cartridges is too small.
These disadvantages similarly hold 1) for manual filling and stoppering machines, which are operated electrically and pneumatically and where the processes are triggered by an operator, 2) for semi automatic filling and stoppering machines, which are operated electrically, electronically and pneumatically and where the operator has to remove the outer bag of the tub and nest assembly and then a top lid from the tub along with an inner sheet, and 3) for fully automatic filling and stoppering machines, which are operated electrically, electronically and pneumatically and where whole packets are inserted into the filling and stoppering machine one by one, the machine will automatically remove the outer bag and then remove the top lid from the tub by means of an automatic peeling off unit, then the inner sheet of the tub and nest assembly will be removed automatically and the machine will then automatically pick up the nests by means of a vacuum cup and place them onto transport carriers, which are then moved towards the filling station nozzles for the medicine filling process.
The currently available tub and nest assemblies in the market require the replacement of filling carriers for maintaining an accurate height difference between the filling nozzles and the cartridge top levels. Further after replacement of the filling carriers the replacement parts require separate validation studies as per GMP guidelines requirements. If the tub and nest assemblies available in the market are directly fed for filling of pre-crimped cartridges on the same machine without any alterations in the filling machines then the filling nozzles can be damaged or glass cartridges can be broken because the height difference between the filling nozzles and the pre-crimped cartridges is too small. All the above activities will incur higher costs and also additional time will be required to change the parts resulting in production losses. Further all fully automatic machines and new separate change parts are very expensive.
U.S. Pat. No. 8,561,828 B2 discloses a nest for concurrently holding a plurality of cylindrical pharmaceutical containers, such as vials or cylindrical ampoules, that have no retaining edges like the hand rests of conventional syringe bodies. The nest comprises a plurality of cylindrical receptacles for accommodating the cylindrical containers. At the bottom ends of the receptacles two opposite retaining protrusions are provided, for limiting an axial movement of the cylindrical containers and directly supporting the bottoms of the cylindrical containers. Each receptacle has two opposite apertures so that a lifting element of a manipulating device can directly engage with the bottoms of the containers to properly adjust their height levels. The containers are, however, accommodated upright in the receptacles.
US 2013/0048531 A1 discloses a similar nest, wherein each of the receptacles is formed by a plurality of side-walls that are spaced apart from each other but not unitary, circumferential side-walls. At the bottom ends of the side-walls retaining protrusions are provided. Also this nest can only be used for cylindrical pharmaceutical containers, such as vials or cylindrical ampoules, that have no retaining edges like the hand rests of conventional syringe bodies.
EP 2 183 166 B1 of the same applicant discloses a similar nest where the pharmaceutical containers are either accommodated in tubular receptacles having a closed bottom or hang with their neck portions in openings provided in the supporting plate of the nest.
U.S. Pat. No. 8,118,167 B2 discloses a transport container for sealed prefillable syringe barrels. The transport container accommodates a nest having cylindrical receptacles provided on the upper side thereof. The syringe barrels hang with their hand rests on the upper rims of the cylindrical receptacles. The bottom ends of the syringe barrels are sealed and extend into the free inner volume of the transport container. The bottom ends of the syringe barrels are not supported by holding members.
US 2013/0161225 discloses a further packaging unit for storing syringe barrels, wherein the syringe barrels again hang with their hand rests on the upper rims of the cylindrical receptacles. An upper lid can be clipped onto the nest to secure the syringe barrels and provide an integral cover. A similar tube storage rack is disclosed by U.S. Pat. No. 3,643,812.
US 2005/0214924 A1 discloses a supporting structure for sampling tubes containing culture growth media. The supporting structure comprises a supporting plate having a plurality of cup-shaped receptacles with bottoms on which the bottoms of the sampling tubes are directly supported. Here, the sampling tubes are supported in an upright position and with their upper ends protruding beyond the supporting plate so that the filling openings are easily accessible.